Product Details for NDA 201370
HEPARIN SODIUM (HEPARIN SODIUM)
1,000 UNITS/ML
Marketing Status: Prescription
5,000 UNITS/ML
Marketing Status: Prescription
1,000 UNITS/ML
Marketing Status: Prescription
10,000 UNITS/ML
Marketing Status: Discontinued
1,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N201370
Product Number: 001
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N201370
Product Number: 001
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
5,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N201370
Product Number: 002
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
HEPARIN SODIUM PRESERVATIVE FREE (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N201370
Product Number: 002
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
1,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N201370
Product Number: 004
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
HEPARIN SODIUM (HEPARIN SODIUM)
Proprietary Name: HEPARIN SODIUM PRESERVATIVE FREE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N201370
Product Number: 004
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Prescription
Patent and Exclusivity Information
10,000 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: HEPARIN SODIUM
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N201370
Product Number: 003
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HEPARIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10,000 UNITS/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N201370
Product Number: 003
Approval Date: Jul 21, 2011
Applicant Holder Full Name: PFIZER INC
Marketing Status: Discontinued
Patent and Exclusivity Information